Diprosalic®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIPROSALIC® (DIPROSALIC®)

Composition:

Active substances: betamethasone, salicylic acid;

1 g of ointment contains betamethasone dipropionate 0.64 mg, equivalent to 0.5 mg of betamethasone, and salicylic acid 30.0 mg;

Excipients: mineral oil, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: homogeneous, soft ointment of almost white color, free from foreign particles.

Pharmacotherapeutic group.

Corticosteroids for dermatological use. Potent corticosteroids in combination with other agents. ATC code D07XC01.

Pharmacological properties.

Pharmacodynamics.

Betamethasone dipropionate

Betamethasone dipropionate belongs to potent corticosteroids. When applied locally, it exerts rapid and prolonged anti-inflammatory, antipruritic, and vasoconstrictive effects.

Local treatment with corticosteroids is not etiologic therapy; upon discontinuation of treatment, recurrence of the disease is possible.

Salicylic acid

Salicylic acid, due to its keratolytic and desquamating properties, makes the lower layers of the skin more accessible to the action of betamethasone dipropionate and enhances its absorption.

Pharmacokinetics.

Systemic absorption of betamethasone dipropionate is possible, primarily after prolonged application over a large skin surface area.

Clinical characteristics.

Indications.

Local treatment of dermatoses sensitive to corticosteroids, such as: chronic, erythematous, or hyperkeratotic psoriasis, and other erythematous-squamous dermatoses, such as seborrheic dermatitis (eczema), dry eczema in the desquamative phase, lichenification.

Contraindications.

The drug is contraindicated in patients with hypersensitivity to the active substances or to any other component of the drug.

The drug is also contraindicated in bacterial and viral infections, such as syphilitic and tuberculous skin lesions; post-vaccination reactions, smallpox, chickenpox, herpes simplex, herpes zoster, perioral dermatitis, perianal pruritus, and genital pruritus; generalized plaque psoriasis, varicose veins, diaper dermatitis, molluscum contagiosum, dermatomycoses, rosacea, acne, fungal infections.

Avoid contact of the drug with wounds, ulcers, or mucous membranes. Diprosalik® is not intended for ophthalmic use or under occlusive dressings.

Interaction with other medicinal products and other forms of interaction.

There is no information about cases of interaction with other medicinal products.

Topical application of salicylic acid should not be combined with oral administration of drugs containing acetylsalicylic acid and other nonsteroidal anti-inflammatory agents. Do not use simultaneously with benzoyl peroxide and topical retinoids. Salicylic acid may enhance skin permeability to other topical medicinal products, thereby increasing their systemic absorption. In addition, salicylic acid may potentiate the adverse effects of methotrexate and the hypoglycemic effect of oral antidiabetic agents—sulfonylurea derivatives. If you are taking any other medicinal products, be sure to inform your physician.

Special precautions for use

If skin irritation or signs of hypersensitivity occur, treatment should be discontinued and appropriate therapy should be selected for the patient.

Any adverse effects observed during systemic corticosteroid use, including suppression of adrenal cortex function, may also occur with topical application of glucocorticosteroids, particularly in children.

Systemic absorption of topical corticosteroids increases with larger treated body surface areas or when occlusive dressings are used. In such cases or during prolonged use, appropriate precautions should be taken.

High-potency corticosteroids applied over large skin areas should be used under careful and periodic monitoring, as they may suppress the hypothalamic-pituitary-adrenal (HPA) axis. If suppression develops, the drug should be discontinued, the frequency of application reduced, or the patient switched to a less potent corticosteroid.

HPA axis function usually recovers after discontinuation of the drug. In some cases, withdrawal symptoms may develop, requiring supplementation with systemic corticosteroids.

When scaling or hyperkeratosis resolves, treatment should continue with corticosteroids only.

The use of the drug under occlusive dressings is not recommended.

If excessive dryness or worsening skin irritation occurs, the drug should be discontinued.

Topical corticosteroids may, for various reasons, induce psoriasis, including symptom recurrence, followed by the development of tolerance, risk of pustular psoriasis, and local systemic toxicity due to impaired skin barrier function. Patients with hepatic dysfunction are more sensitive to systemic effects. Close monitoring of the patient is required.

If infection is present, appropriate antifungal or antibacterial agents should be administered. If the desired effect is not rapidly achieved, corticosteroid use should be discontinued until signs of infection resolve.

Appropriate precautions should be taken to prevent increased absorption when the drug is applied to damaged skin, atrophic skin, large body surface areas, under occlusive dressings, or in children (due to higher body surface area-to-body weight ratio). When applied to large body surface areas, absorption of salicylic acid should also be considered.

Topical corticosteroids may alter the clinical picture.

Relapse may occur upon interruption of treatment, and infection exacerbation and delayed wound healing are possible.

The drug should not be applied to mucous membranes or areas around the eyes due to the keratolytic effect of salicylic acid.

Application of the drug to areas with atrophic skin is contraindicated.

Visual disturbances

Visual disturbances may occur with systemic and topical use of corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should undergo an ophthalmological examination to evaluate possible causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding

Should not be used during the first trimester of pregnancy.

Since the safety of topical corticosteroids in pregnant women has not been established, these drugs should be prescribed only if the expected benefit to the mother clearly outweighs the potential risk to the fetus. Drugs of this group are contraindicated in high doses, for prolonged periods, or over large skin areas during pregnancy.

It is currently unknown whether topical corticosteroids, due to systemic absorption, can pass into breast milk; therefore, a decision should be made whether to discontinue breastfeeding when prescribing this drug.

Ability to influence reaction speed while driving or operating machinery

The drug usually does not affect reaction speed while driving or operating machinery.

Method of Administration and Dosage

Apply a thin layer of the ointment to the affected area twice daily, in the morning and evening, allowing it to penetrate the skin with gentle massage. For some patients, satisfactory results may be achieved with once-daily application.

The maximum daily dose should be gradually reduced to the lowest possible dose that still controls symptoms.

Children.

There are no clinical data on the use of the drug in children; therefore, its use in this age group is not recommended.

Since the surface area to body weight ratio is higher in children than in adults, absorption of the drug is more pronounced. Therefore, children are more susceptible to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and the development of exogenous corticosteroid effects following topical corticosteroid use.

In children treated with topical corticosteroids, adrenal suppression, Cushing's syndrome, growth retardation, inadequate weight gain, and increased intracranial pressure have been observed.

Signs of adrenal cortex suppression include low plasma cortisol levels and lack of response to adrenocorticotropic hormone (ACTH) stimulation tests. Increased intracranial pressure may present as bulging fontanelle, headache, and bilateral optic disc swelling.

Since corticosteroids may affect growth hormone production in children, body weight and growth should be closely monitored in pediatric patients.

Overdose.

Excessive or prolonged use of topical preparations containing salicylic acid may lead to symptoms of salicylism.

Application of large doses may enhance keratolytic effects and increase the risk of allergic reactions.

Treatment. Appropriate symptomatic therapy should be administered. Symptoms of acute hypercorticism are usually reversible. If necessary, correct electrolyte imbalances. In cases of chronic toxic effects, gradual withdrawal of corticosteroids is recommended.

Treatment of salicylism is symptomatic. Measures should be taken to accelerate elimination of salicylates from the body. In case of overgrowth of resistant microorganisms, treatment with the drug should be discontinued and appropriate therapy initiated. Orally administer sodium bicarbonate to alkalinize urine and enhance diuresis.

Side effects.

Corticosteroids are locally absorbed through the skin. However, systemic effects of the drug may occur with prolonged use and/or application to large areas of skin, particularly in children.

Systemic effects may partially manifest as suppression of the hypothalamic-pituitary-adrenal (HPA) axis, leading to secondary adrenal insufficiency, including Cushing's syndrome. Children may absorb higher amounts of corticosteroids, making pediatric patients more susceptible to systemic effects of the drug, even with application of less than 30 g per week. Patients with severe hepatic impairment are also more sensitive to the development of these effects.

Possible side effects associated with the use of topical corticosteroids include: burning sensation, itching, irritation, dryness, stinging, skin tightness, skin cracking, sensation of warmth, lamellar desquamation, focal desquamation, erythema, telangiectasia, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, and allergic contact dermatitis.

As with any medicinal product applied to the skin, allergic reactions during application of Diprosalic® ointment are possible.

When applying the product over large areas or under occlusive dressings, especially for prolonged periods, the potential for systemic effects should be considered.

Hypersensitivity reactions may occur in individuals with known hypersensitivity to any component of the product.

Diprosalic®, ointment, is a colorless preparation and does not stain clothing.

Cases of blurred vision have been reported with corticosteroid use (see also section "Special precautions for use") (frequency unknown).

Any adverse effects observed with systemic administration of glucocorticoids, including suppression of the adrenal cortex, may also occur with topical application of glucocorticosteroids.

The following adverse reactions may occur more frequently when occlusive dressings are used: skin maceration, secondary infection, skin atrophy, striae, and miliaria.

Striae and vascular dilation, particularly on the face, may result from prolonged continuous application of the product.

Shelf life. 3 years.

Storage conditions.

Store out of reach of children at a temperature not exceeding 25 °C.

Packaging.

30 g in tubes. 1 tube per cardboard box.

Prescription status. Prescription only.

Manufacturer.

Organon Heist bv, Belgium.

Manufacturer's address and place of business.

Industriepark 30, 2220, Heist-op-den-Berg, Belgium.